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Mammosite Breast Brachytherapy Optimization in the Treatment of Breast Carcinoma

NCT00611624 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-05-16

Study results available
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Summary

The purpose of this study is to determine if Mammosite Catheter optimization using multiple dwell position delivery decreases skin toxicity over historically reported skin toxicity with the single dwell delivery method.

Conditions

  • Breast Neoplasms

Interventions

RADIATION

Mammosite brachytherapy radiation

Treatment using MammoSite will begin within five days of placement of the catheter. Only high dose rate (HDR) with Ir-192 treatment is allowed. The balloon will remain inflated throughout the treatment course. A total of 34 Gy will be prescribed to an approximate 1 cm radial distance from the balloon surface. Two fractions per day, each of 3.4 Gy, separated by at least 6 hours, given on 5 treatment days (over a period of 5 to 10 days), will sum to 10 fractions and 34 Gy.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Joanne Weidhaas, M.D., Ph.D. · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00611624 on ClinicalTrials.gov